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NCT05282732 Clinical Trial

Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients

End Stage Renal Disease Clinical Trial

— Genius  

Official title:
Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Acute Haemodialysis, Haemodynamically Instable Patients and Chronic Haemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05282732
Other study ID # Genius-AKI-01-D
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 7, 2022
Est. completion date December 2024

Study information
Verified date February 2024
Source Fresenius Medical Care Deutschland GmbH
Contact Tatiana De los Rios
Phone +49 6172 608 2362
Email Tatiana.De-Los-Rios@fmc-ag.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Retrospective analysis of performance and treatment data collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in acute haemodialysis, haemodynamically instable patients and chronic haemodialysis patients - to analyse performance and treatment data from patients treated with the investigational device - to evaluate the filter characteristics for aHD (Acute haemodialysis) patients - to evaluate the improvement of kidney function for aHD patients

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All patients with an indication for the extracorporeal blood treatment suffering from renal insufficiency who received all treatments, between January 2019 and December 2019, with the investigational devices have to be included in the study in chronological order. - For aHD patients: availability of at least 3 of the 5 primary variables (daily urea, creatinine, potassium, ultrafiltration and effluent volume) for 50 % of the documented treatments. - For cHD patients: availability of the ultrafiltration values for all treatments and at least one value for urea and creatinine per week Exclusion Criteria: - Simultaneous use of another filter/adsorber for another form of therapy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Medizinische Hochschule Hannover Hannover
Germany Universitätsklinikum Jena Jena

Sponsors (2)
Lead Sponsor Collaborator
Fresenius Medical Care Deutschland GmbH Alcedis GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Daily values for urea, Unit: mg/dl or mmol/L Acute haemodialysis patients During the intervention
Primary Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L Acute haemodialysis patients During the intervention
Primary Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L Acute haemodialysis patients During the intervention
Primary Ultrafiltration volume (UF) and Effluent volume (per treatment) Acute haemodialysis patients During the intervention
Primary Values for urea and creatinine (measured according to the clinical practice of the site) Chronic haemodialysis patients During the intervention
Primary Planned and delivered UF-volume (per treatment) Chronic haemodialysis patients During the intervention
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